Cleared Traditional

K182062 - Sysmex UD-10

K182062 is the FDA 510(k) clearance for Sysmex UD-10 by Sysmex America, Inc.. It is a Class 2 Hematology device (product code JOY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K182062 · Sysmex America, Inc. · Hematology device
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Oct 2018
Decision
90d
Days
Class 2
Risk

K182062 is an FDA 510(k) clearance for the Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on October 30, 2018 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5260 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sysmex America, Inc. devices

Submission Details

510(k) Number K182062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2018
Decision Date October 30, 2018
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOY Device, Automated Cell-locating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JOY Device, Automated Cell-locating

All 7
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K182062.
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
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K200595 · CellaVision AB · Oct 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
K201301 · Scopio Labs , Ltd. · Oct 2020
EASYCELL CELL LOCATOR
K092116 · Medica Corp. · May 2010
SCANNING SYS., AUTO. COMP., ACS1000
K772140 · Honeywell, Inc. · Dec 1977